FDA 483 - American National Red Cross, Penn Jersey Region - June 04, 2010

The FDA Form 483 details observations from an inspection, highlighting failures in quality systems and adherence to standard operating procedures.

**Key Violations and Observations:**

1. **Inadequate Investigation and Follow-up of Discrepancies:** * **Exception E-0585021 (5/21/09):** An employee performed an arm preparation inappropriately, affecting 359 whole blood units. While initial gain control was within 48 hours, three in-date AS-1 red blood cells (units 022N710611, 022N710613, 022N710616) were not recalled, and consignees were not notified until 5/28/10, after CBER inquiry on 4/5/10. A problem (E-031697) for recall follow-up failure was not logged until 6/2/10.

2. **Failure to Follow Written Standard Operating Procedures (SOPs):** * **Work Instruction 11.3.090 (Retrieval/Notification of Transfusable Components):** * **Exception E-0501484 (1/9/09):** A male donor was registered as female, requiring retrieval. Initial notification was sent